NIMble innovation-a networked model for public antibiotic trials

NIMble innovation-a networked model for public antibiotic trials
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DOI:
10.1016/s2666-5247(21)00182-8
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发表时间:
2021-11-02
期刊:
影响因子:
38.2
通讯作者:
Kirchhelle, Claas
Kirchhelle, Claas
中科院分区:
生物学1区
文献类型:
--
作者:
Glover, Rebecca E.;Singer, Andrew C.;Kirchhelle, Claas

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抗生素的研究和开发正处于拐点。面对商业创新方面持续存在的问题,我们主张采用网络化的公共方法来支持和协调现有的研究和开发计划,通过临床试验可持续地推动有前途的化合物。我们建议建立一个全球公共基础设施机构,其任务是(1)进行所有试验阶段直至市场授权,包括小规模化合物生产; (2) 与行业合作伙伴谈判全球生产和发行的许可协议; (3) 使用公共采购协议或订阅模式确保以公平的价格进行商业上可行的药品生产。我们邀请利益相关者考虑我们的网络研究所模型对于畅通公共和私人抗生素管道的好处。
Antibiotic research and development is at an inflection point. Faced with ongoing problems with commercial innovation, we argue for a networked public approach to support and coordinate existing research and development initiatives by sustainably moving promising compounds through dinical trials. We propose a global public infrastructure of institutes tasked with (1) conducting all trial stages up to market authorisation, including small-scale compound production; (2) negotiating licensing agreements for global production and distribution by industry partners; and (3) using public purchasing agreements or subscription models to ensure commercially viable drug production at equitable prices. We invite stakeholders to consider our Networked Institute Model's benefits for unblocking the public and private antibiotic pipeline.